510(k) · Cleared
ClearedDukal Corporation Level 1 Pediatric Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dukal Corporation · OXZ Pediatric/Child Facemask
Cleared on Mar 29, 2022 as substantially equivalent to K160100 (Prestige Ameritech, 2016) after a 418-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Mar 29, 2022
- Review
- 418 days
- Class
- Class II
- Product code
- OXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970835 (1997). 12 ancestors in all, the oldest K801036 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 6 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 5 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 4 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 3 generations backK103150 Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark · 2011
- 2 generations backK113340 Kimberly-Clark Child's FacemaskKimberly-Clark · 2012
- 1 generation backK160100 Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech · 2016
- This deviceK210321 Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation · 2022
- Descendant · cites it directly · 0 of its ownK213427 PRIMED Pediatric FacemaskPrimed Medical Products, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −6 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −5 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −4 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −3 | K103150 | Kimberly-Clark Child/Pediatric Face Mask | Kimberly-Clark | 2011 | — |
| −2 | K113340 | Kimberly-Clark Child's Facemask | Kimberly-Clark | 2012 | — |
| −1 | K160100 | Prestige Ameritech Pediatric/Child’s Face mask | Prestige Ameritech | 2016 | — |
| 0 (this device) | K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022 | — |
| +1 | K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OXZ device
- #1 K221753 Kangbeier Child Surgical Maskscore 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160100 | Prestige Ameritech Pediatric/Child’s Face maskSummary page 4…OXZ 12. Predicate Device: Prestige Ameritech Pediatric/Child Face Mask (level 1) • 510k #K160100, cleared on 10/7/2016 13. Device Description: Pediatric face masks are intended to be worn by the… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213427 | PRIMED Pediatric Facemask | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K213427 (Primed Medical Products, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160100.
How does its category compare?
All OXZ devicesOXZ Pediatric/Child Facemask: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OXZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OXZ
Too few OXZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OXZ
No recall names OXZ since 2007.
Adverse event reports per year · OXZ
1in 2023
MAUDE reports naming product code OXZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210321 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210321: Dukal Corporation Level 1 Pediatric Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210321
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026